HR 843 · 119th CongressIn Committeecongress.gov ↗

Prompt Approval of Safe Generic Drugs Act

What this bill does

AI plain-language summary

This bill allows the Food and Drug Administration to approve generic drugs even when their labels don't include certain safety information that is protected by patents or exclusivity rights of other drugs. Currently, generic drug labels must generally be identical to the original drug's label. The bill creates an exception to this rule when safety information is protected by patents. However, the FDA must still require generic drug labels to include any safety information that is necessary for safe use.

Introduced

January 31, 2025

Policy Area

Health

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